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Effect of linalotide combined with compounded polyethylene glycol electrolyte dispersion in bowel preparation prior to colonoscopy: a randomized, controlled, single-blind, single-centre, non-inferiority trial

Effect of linalotide combined with compounded polyethylene glycol electrolyte dispersion in bowel preparation prior to colonoscopy: a randomized, controlled, single-blind, single-centre, non-inferiority trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065832
Enrollment
Unknown
Registered
2022-11-16
Start date
2022-11-22
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal diseases

Interventions

Experimental group 1:The day before colonoscopy, 290ug linalotide was taken orally before lunch/dinner, and 2L PEG was taken orally 4~6 hours before the operation on the same day
Experimental group 2:Oral administration of 580ug linaclotide before dinner the day before colonoscopy, and oral administration of 2L PEG 4~6 hours before the procedure on the same day
Control group:Take 1L PEG orally the night before colonoscopy, and 2L PEG 4~6 hours before the same-day operation

Sponsors

General Hospital of the Northern Theater of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 19 years old, male or female; 2. Be able to understand the procedures and methods of this study, be willing to sign the informed consent form and strictly abide by the clinical research protocol to complete the study.

Exclusion criteria

Exclusion criteria: 1. Known or suspected allergy to colon cleansing drug ingredients; 2. Suspicious or definite mechanical intestinal obstruction, perforation, toxic megacolon, intestinal foreign body; 3. After colon surgery; 4. Patients with active inflammatory bowel disease or diverticulitis; 5. Heart failure (NYHA grade III to IV), kidney failure, liver failure; 6. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Boston bowel preparation score;

Secondary

MeasureTime frame
Polyp detection rate (PDR) and adenoma detection rate (ADR) of the entire colon, calculated as the percentage of patients with at least one polyp (PDR) or adenoma (ADR), cecal intubation rate;Tolerance and safety;

Countries

China

Contacts

Public ContactYang Zhuo

General Hospital of the Northern Theater of the Chinese People's Liberation Army

yangzhoucy@163.com+86 13309888172

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026